Dairy Products, Diabetes and Genetics

NCT02961179 | Completed

• 1 other identifier: 2017-3228
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the in-depth the benefits of dairy consumption on glucose metabolism in patients at risk of type 2 diabetes using novel genomics methodology.To do so, 33 individuals at risk of type 2 diabetes will be randomly subjected to an intervention study including a 6-week intensive dairy product consumption period and a 6-week dietary counselling period.

Conditions

Insulin Sensitivity; Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change from baseline to 6 weeks in insulin sensitivity between high dairy and dietary counselling phases

  2h-oral glucose tolerance test (OGTT)

  Change from 0 to 6 weeks

Secondary Outcomes (16)

• Change from baseline to 6 weeks in fasting glucose between high dairy and dietary counselling phases

  Change from 0 to 6 weeks

• Change from baseline to 6 weeks in 2 h plasma glucose post OGTT between high dairy and dietary counselling phases

  Change from 0 to 6 weeks

• Change from baseline to 6 weeks in insulin secretion (Insulinogenic index ) between high dairy and dietary counselling phases

  Change from 0 to 6 weeks

• Change from baseline to 6 weeks in insulin secretion (area under the curve of C-peptide) between high dairy and dietary counselling phases

  Change from 0 to 6 weeks

• Change from baseline to 6 weeks in b-cell function (disposition index) between high dairy and dietary counselling phases

  Change from 0 to 6 weeks

Study Arms (2)

Increased dairy product

EXPERIMENTAL

Subjects will be asked to consume a total of 3 to 5 servings per day.They will be instructed on options and variations for incorporating the dairy foods into their routine dietary pattern.

Behavioral: Increased dairy product

Dietary counselling

PLACEBO COMPARATOR

Subjects will review the standard dietary recommendation(http://www.diabetes.ca/diabetes-and-you/nutrition/meal-planning-guide/) by a registered dietitian.

Behavioral: Dietary counselling

Interventions

Increased dairy product BEHAVIORAL

Increased dairy product

Dietary counselling BEHAVIORAL

Dietary counselling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caucasian men and postmenopausal women (absence of menstrual cycles for \>12 months) aged \>18 yrs;
• BMI between 25-40 kg/m2;
• Hyperinsulinemia (fasting plasma insulin \>90 pmol/l);
• Fasting plasma glucose (FPG) \<7.0 mmol/l; HbA1c \<6.5%);
• If treated with lipid-lowering agents, the dose must have been stable over the last 3 months;
• Stable body weight (±5%) for 3 months;
• Willing to consume study foods and able to follow protocol and give informed consent.

You may not qualify if:

• Diagnosis of type 2 diabetes;
• High dairy consumption ( 2 servings/day or more);
• Major surgery in the 3 months prior to study onset;
• Smoking;
• Incompatibility with dairy consumption (allergy, intolerance or dislike);
• Inflammatory bowel disease or other gastrointestinal disorder influencing gastrointestinal motility or nutrient absorption;
• Medications known to affect lipid and glucose metabolism other than those used to treat hypertension or dyslipidemia;
• Diseases known to affect glucose metabolism.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Research Center CHU de Quebec-Université Laval

Québec, Quebec, G1V 4G2, Canada

Location

Related Publications (4)

• Arghavani H, Bilodeau JF, Rudkowska I. Impact of dairy intake on circulating fatty acids and associations with blood pressure: A randomized crossover trial. Nutr Metab Cardiovasc Dis. 2025 Sep;35(9):104112. doi: 10.1016/j.numecd.2025.104112. Epub 2025 Apr 30.

  PMID: 40436701 DERIVED

• Khorraminezhad L, Rudkowska I. Modulation of gene expression profile following consumption of high-dairy products in subjects with hyperinsulinemia. Nutr Metab Cardiovasc Dis. 2023 Jan;33(1):219-226. doi: 10.1016/j.numecd.2022.10.015. Epub 2022 Nov 1.

  PMID: 36411217 DERIVED

• Khorraminezhad L, Rudkowska I. Dairy Product Intake Modifies MicroRNA Expression among Individuals with Hyperinsulinemia: A Post-Intervention Cross-Sectional Study. Lifestyle Genom. 2022;15(3):77-86. doi: 10.1159/000523809. Epub 2022 Feb 25.

  PMID: 35220313 DERIVED

• O'Connor S, Julien P, Weisnagel SJ, Gagnon C, Rudkowska I. Impact of a High Intake of Dairy Product on Insulin Sensitivity in Hyperinsulinemic Adults: A Crossover Randomized Controlled Trial. Curr Dev Nutr. 2019 Jul 24;3(8):nzz083. doi: 10.1093/cdn/nzz083. eCollection 2019 Aug.

  PMID: 31453424 DERIVED

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 10, 2016
• Study Start: January 1, 2017
• Primary Completion: July 13, 2018
• Study Completion: July 13, 2018
• Last Updated: March 1, 2019

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)